Recall Z-2453-2021— Accora Inc

Class II FDA medical device recall by Accora Inc, initiated 2021-06-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030; Advance Chair, 100mm (4in) Castors, Std Backrest, Electric; Serial Numbers: 10001-SC2-20 to 10135-SC2-20; 10001-SC2-21 to 10240-SC2-21. Model Number: CHAIR-0-SC3-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Manual; Serial Numbers: 10116-SC3-20 to 10145-SC3-20; 10236-SC3-20 to 10295-SC3-20; 10001-SC3-21 to 10090-SC3-21; 10271-SC3-21 to 10360-SC3-21; 10001-SC3-20 to 10115-SC3-20; 10146-SC3-20 to 10235-SC3-20. Model Number: CHAIR-0-SC4-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Electric; Serial Numbers: 10001-SC4-20 to 10030-SC4-20.. Reason: The firm has identified a potential for the backrest to become detached from the chair..

Recalling firm

Accora Inc

Classification

Class II

Status

Ongoing

Initiated

2021-06-21

Firm location

Rockville, MD, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.